Pull-Locking Rotational Action Needle Driver

ABSTRACT

A pull-locking rotational action needle driver that comprises an ergonomically designed handle and an integrated locking system that permits left and right handed surgeons to perform the surgical suturing procedure in a less complicated and more secure way by allowing more control over the suturing needle and the area to be stitched, even when the suturing area is small, deep, and/or restricted.

RELATED APPLICATIONS

This application is related to U.S. patent application Ser. No.11/186,704 filed on Jul. 20, 2005.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH AND DEVELOPMENT

N/A

BACKGROUND OF INVENTION

1. Field of the Invention

The present invention relates generally to a surgical suturing device,more specifically, to a ergonomic Pull-Locking Rotational Action NeedleDriver which enhance the tissue suturing procedure, particularly the oneperformed on restricted, deep and less accessible locations, byincorporating a pull-locking mechanism that prevents problems associatedwith loss of needle control during the suturing procedure and the onesassociated with prior needle driver's handedness. It also enhances thecontrol surgeons has over the suturing needle by enabling a rotationalmovement while driving the suturing needle through the tissue thatpermits to place the needle in the right location in order to continuethe subsequent steps of the suturing cycle.

2. Background of the Invention

Surgical procedures have proliferated among the medical practice as newtreatments are developed to effectively treat common and extraordinaryconditions. The spectrum of invasiveness goes from simple tissuesuturing of small open wounds to complicated procedures as thoseperformed in vascular or neurological surgeries. It is undoubted thateach and every step on any surgical procedure is of great importance andcould cause negative consequences for the patient if it is inadequatelyperformed. The suturing procedure, in particular, could end in seriousconsequences for the patient if negligently conducted, causing damagesto adjacent tissues or even organs.

It is known that the suturing procedure consumes a considerable amountof time of the surgical treatment. Simplification of the suturingprocedure by developing more effective suturing devices will reduce thetime spent on that task and at the same time will reduce the risk ofnegative consequences arising from damages caused to adjacent tissues ororgans.

Generally, the instruments used in suturing procedures are the suturingmaterial, the suturing needle and the suturing driver. Efforts made toreduce the suturing time and to enhance the suturing procedures' safetyhave been focused on performing needle driver's modifications. One ofthe generally unattended deficiencies of the available needle drivers isthe handedness of its designs. For instance, Scalani, Jr, in U.S. Pat.No. 4,161,951 discloses a device to drive a needle through the bonystructure of the sternum and to facilitate closing the chest cage afterthoracic surgery.

Similarly, Yoon in U.S. Pat. No. 5,759,188 discloses a suturinginstrument comprising a needle driver and a needle catcher to be used inlaparoscopic procedures.

Alternatively, Stoianovici in U.S. Pat. No. 6,400,979 B1 discloses amethod of performing a radiological imaged guided percutaneous surgerywith a system including a radiological image generating device forgenerating images of the targeted area, and a needle insertion mechanismdisposed adjacent the image generating device.

On the other hand, McGarry U.S. Pat. No. 6,520,973 B1 discloses vascularanastomosis incorporating sutures for joining a graft blood vessel to atarget blood vessel such as the aorta or coronary artery. The entirecontent of all of the above cited U.S. patents are hereby incorporatedby reference.

However, one of the generally unattended deficiencies of the availableneedle drivers is the handedness of its designs. Ordinarily, needledrivers are designed to fit right handed users. Thus, left handed usershave difficulties performing the suturing procedure. The righthandedness of those devices further affects the capacity of left handedsurgeons to lock and unlock the drivers' locking mechanism. Thisincreases the risks of negative outcomes for patients from wrong needledriver maneuverings. That is why latest suturing devices very often failto ease the drivers handling. The available drivers without handednessare very delicates because are mostly designed for ocular andmicrovascular procedures.

SUMMARY OF THE INVENTION

The disclosed embodiment of the present invention helps provide aneffective suturing device that enhances the maneuvering and safety ofsuturing procedures. The disclosed invention consists of a suturingneedle driver that comprises an ergonomical handle that eases thesuturing process to right and left handed users. It also comprises alocking mechanism that permits users to maintain the needle tightlyfixed to the needle driver in order to have a best control over theneedle and the movements related to the suturing process. The disclosedinvention also contains a rotational knob that provides additionalcontrol over the movements related to the suturing procedure. It permitsthe user to position the suturing needle at the exact angle at which thesuturing material has to be inserted into the tissue.

Therefore, it can be appreciated that there exist a prevalent necessityfor new and improved ergonomical suturing device to perform safest andsimplest suturing procedures. In this regard, the present inventionsubstantially fulfills this need. The present invention overcomes theinability of the prior art to foresee the need of an ergonomicalsuturing needle driver that permits left and right handed users toperformed safe suturing procedures. Furthermore, the invention isintended to provide an ergonomical suturing needle driver comprising apull locking mechanism that can be effectively operated by left andright handed users.

Another deficiency presented by the prior art is the lack of disclosureof needle driver having a rotational mechanism that permits to fix theneedle to a specific angle before inserting it into the tissue andcombining the said rotation with ergonomic characteristics in order tofacilitate the suturing processes.

None of the prior art considered above, taken either simply or incombination teaches the use of a suturing needle driver suitable to leftand right handed users and comprising a pull locking mechanism and arotational mechanism. In light of the foregoing, it will be appreciatedthat what is needed in the art is a suturing needle driver lacking ofhandedness and combining a pull locking mechanism and a rotationalmechanism. Thus, the object of the present invention is to provide asurgical device that eases the suturing procedure associated with deep,restricted areas.

Another object of the present invention is to provide a surgicalsuturing needle driver that permits to grasp, secure and rotate a curvedsurgical needle without requiring a rotational motion at the surgeon'swrist.

It is the object of the present invention to provide a surgical suturingneedle driver which incorporates a pull-locking rotational mechanismthat secures the needle to the needle driver and permits to diminish thenumber of maneuvers actually needed for performing the surgical suturingprocess, reducing the risk of damaging peripheral tissues.

It is a further object of the present invention to provide anergonomically designed suturing needle driver that eliminates thedifficulties associated with needle driver maneuvering that arise fromthe handedness of that kind of instrument.

The system of the invention itself both as to its configuration and itsmode of operation will be best understood, and additional objects andadvantages thereof will become apparent, by the following detaileddescription of a preferred embodiment taken in conjunction with theaccompanying drawing.

When the word “invention” is used in this specification, the word“invention” includes “inventions”, that is, the plural of “invention”.By stating “invention”, the Applicant does not in any way admit that thepresent application does not include more the one patentable andnon-obviously distinct invention and Applicant maintains that thepresent application may include more than one patentably andnon-obviously distinct invention. The Applicant hereby asserts, that thedisclosure of the present application may include more than oneinvention, and, in the event that there is more than one invention, thatthese inventions may be patentable and non-obvious one with respect tothe other,

Further, the purpose of the accompanying abstract is to enable the U.S.Patent and Trademark Office and the public generally, and especially thescientists, engineers, and practitioners in the art who are not familiarwith patent or legal terms or phraseology, to determine quickly from acursory inspection the nature and essence of the technical disclosure ofthe application. The abstract is neither intended to define theinvention of the application, which is measured by the claims, nor is itintended to be limiting as to the scope of the invention in any way.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a two-dimensional view of the Pull-locking RotationalAction Needle Driver device.

FIG. 2A shows the Pull-locking Rotational Action Needle Driver deviceunlocked.

FIG. 2B shows the Pull-locking Rotational Action Needle Driver devicelock over the first tooth over the triple-teeth component.

FIG. 2C shows the Pull-locking Rotational Action Needle Driver devicelock over the last opposing tooth over the triple-teeth component.

FIG. 2D shows the Pull-locking Rotational Action Needle Driver deviceunlock at the position of the sequential motion locking mechanism.

DESCRIPTION OF THE PREFERRED EMBODIMENT

Turning to the diagram, FIG. 1 shows the device of the present inventioncomprising two rods 9, 10 which approximate to each other resembling apair of chopsticks. At the distal end of each rod 9, 10 the surface isfluted creating a needle-grasping portion 12, 13. The proximal ends ofthe rods 9, 10 have round contours. These rounded ends are embedded inits corresponding sockets located in the handle 1 of the invention. Thehandle 1 is ergonomically designed to rest against surgeon's palm hishand, permitting its proper use to right and left handed surgeons. Thesurgeon will maintain the handle 1 fixed to the palm his hand by usinghis thumb. The rods 9, 10 are fixed to the sockets by a transverse plate3. The proximal ends serve as pivot points and rotational axis as therods 9, 10 move towards or away from each other. The rods 9, 10 aresurrounded near its distal ends by a harness 11 that comprises twoindependent channels, one for each rod 9, 10. The channels are slightlywider than the rods 9, 10. The harness 11 is connected to the pullingpiece 6 by means of a connecting bar 8. The pulling piece 6 is designedas the harness 11 but is wider than the harness 11. The width differenceis provoked by the angle created between the rods 9, 10 at its proximalends. The pulling piece 6 comprises two pulling tabs 4, 7. Surgeon issupposed to place his middle finger around the inferior pulling tab 4.The index finger can be placed around the superior pulling tab 7 whenfurther control is needed during suturing maneuvers. The ring and littlefingers may rest against the handle 1. A locking mechanism 2 a, 2 b islocated between the pulling piece 6 and the handle 1. It comprises twoparallel small bars. One bar is attached to the pulling piece 6 and theother to the transverse plate 3. Each bar has triangular shaped teeth atits distal ends. The bar connected to the transverse plate 3 has threeteeth and the one connected to the pulling piece 6 has one tooth. Thebars are parallel positioned in order to make the teeth of one bar tomeet against the other's tooth. The locking mechanism 2 a, 2 b isshifted to one rod 9, in order to make space for a turning knob 5 thatis placed around the other rod 10. The turning knob 5 will be operatedwith the surgeon's thumb. The turning knob 5 permits to rotate the rods9, 10 and, consequently, the needle.

When the suturing procedure begins, the curved needle is perpendicularlyplaced at the distal end 13, 14 of the invention. For the needle to betightly fixed to the invention, the surgeon has to pull the pullingpiece 6 towards the handle 1. This makes the harness 11 to move towardthe handle 1 too, making the rods 9, 10 to come closer and consequentlytightening the needle, The movement towards the handle 1 makes the twobars comprised in the locking mechanism 2 a, 2 b to slide in oppositedirections. The apposed slanted faces of those bars slide against eachother in a ratchet motion. When this happens, the invention locks,exerting the necessary force to maintain the needle still. Once theneedle is tightened, the turning knob 5 is turned in order to create arotational movement on the rod 10 where it is attached. The forceexerted on that rod 10 also rotates the other rod 9. When the desiredangle is attained, the surgeon will drive the needle through the tissueas the rods 9, 10 roll the needle out. When the desired rotation iscompleted, the surgeon releases the locking mechanism 2 a, 2 b bypulling towards him the pulling piece 6. This movement is made until thetooth of the locking bar attached to the pulling piece 6 passes the lasttooth of the locking bar attached to the transverse plate 3. When thisoccurs, the locking bar attached to the pulling piece 6 is disengagedfrom the transverse plate 3 locking bar and the invention is finallyunlocked. The bar attached to the pulling piece 6 will be forced downand forward loosening up the rods 9, 10. This method is repeated on theother tissue that wants to be joined to the tissue already perforated bythe needle. All the above is repeated as many times as stitches have tobe performed.

Particularly, the pull locking mechanism in this device is illustratedin FIGS. 2A to 2D, wherein it is shown the stepwise motions of the saidlocking mechanism components relative to each other. In FIG. 2A, thecomponents are shown with the slanted surfaces of the teeth facing eachother. At this point the components are not yet engaged and theinstrument is still unlocked. In FIG. 2B however, the pulling motiondrives the single-toothed component 2 b over the first tooth of thetriple-teeth component 2 a. The flat backsides are apposed and theinstrument is locked. Please note the smooth curved underside of thesingle-toothed component 2 b. This feature will become important oncethe locking mechanism is disengaged. The next step is described in FIG.2C, wherein after further pulling is exerted, the single-toothedcomponent 2 b locks on subsequent opposing teeth. A final pull willdrive the single tooth over the last opposing tooth. At this moment thelocking mechanism is disengaged and the instrument is unlocked as shownin FIG. 2D. The recoil of the instrument will force the componentsapart. Please note the curved underside of the triple-teeth component 2a. The smooth curved outlines of both components will face each other.The single-tooth component 2 b will travel forward to its initialposition as it slides down and under the curved underside of thetriple-teeth component 2 a.

The instrument incorporates several features that set it apart formcommonly used needle drivers. Advantageous aspects of its function willbe presented in the context of specific suturing steps that thisinstrument may improve or eliminate.

A) Rotational Action:

The use of rods that rotate while grasping the needle enables thisinstrument to perform tasks that other drivers cannot perform. The mostimportant of these features is the ability to drive the needlecontinuously through the tissue without the need to release and re-drivethe needle. Once the needle has been rotated to a favorable position itcan be grasped at the other side of the free tissue edge. The needle caneven be repositioned again, if desired, by rolling the graspers or thesurgeon may proceed directly to the other tissue edge. Thus, there is noneed to release, re-grasp, and re-drive the needle. The process isrepeated in the same manner and a suturing cycle is completed.Automatically, this eliminates six steps out of the fourteen needed percycle. In addition, this feature decreases the amount of time, effortand eye-hand coordination that the surgeon invests in performing thesetasks. This is especially true when small needles need to be used. Inthis scenario the surgeon will likely have to pick up the needle andreposition it manually for each tissue purchase that he takes. This isdone so because the size of the needle may make driving and re-drivingthe needle with a conventional driver impractical in terms of time andeffort.

As explained earlier, handling of the needle portends a very seriousoccupational risk for the surgeon. If this instrument can reduce oreliminate this risk, then a very significant benefit can be derived fromusing this needle driver beyond time-efficiency. In addition theinstrument's design allows a reduction or elimination, if desired, ofthe rotational motion required at the surgeon's wrist to drive theneedle through the tissue. This affords the surgeon the capability ofdriving the needle with minimal motion of the hand. In deep tissues thistranslates to more efficient and precise handling of the needle. Such acapability is especially important when vascular structures are in thevicinity of the area to be sutured. Reducing wrist rotation may alsoreduce any potential interference with the line of sight when theoperative spaces are very small or narrow, as in the brain.

B) Pull-Locking Mechanism:

As shown earlier, this design incorporates a pull-locking mechanism thatmakes the instrument more versatile than commonly used needle drivers.The instrument can be locked and unlocked with the same unidirectionalmotion. As a result, the surgeon does not have to move his hand orfingers any differently when locking or unlocking the instrument. Thisfeature reduces the amount of movements and energy expenditure. Thus,the surgeon's hand experiences less fatigue.

Another advantage inherent to the instrument's locking mechanism is thatit eliminates handedness. Common needle drivers are designed to unlockeasily when handled by right-handed surgeons. There are also needledrivers designed for left-handed surgeons. However, for an institutionthis implies doubling the cost of instrumentation for no reason otherthan handedness. By placing the locking mechanism in a neutral positionthis problem is eliminated. The instrument is locked and then unlockedby pulling on the tabs towards the handle. This movement will proceed inthe same direction no matter which hand is used. Therefore, theleft-handed surgeon will not have to spend any excessive time or effortlearning how to compensate for a needle driver's design. Left-handedsurgeons will also avoid the extra energy expenditure that comes withunlocking a right-handed instrument.

C) Finger Positioning:

This instrument is designed so that most fingers can be positionedsimilarly to how they would be poisoned in a commonly used needledriver. This feature makes handling this instrument a more familiarexperience for the surgeon. Although the instrument is different fromthe usual needle drivers it is not designed to feel alien to thesurgeon's hand. Thus, this instrument empowers the surgeon with newcapabilities while retaining a hand position to which he or she isalready accustomed.

D) Multiple Ways to Drive a Needle:

As previously explained this instrument is able to grasp the needle inmultiple ways. The usual needle placement allows needle movement in aplane perpendicular to the instrument's long axis. However, in verydeep, conical spaces this arrangement implies a lot of maneuvering in anattempt to purchase the desired tissue. Adjacent structures mayinterfere with the instrument or with needle movement.

This needle driver design provides for grasping the needle so itscurvature lies in plane with the long axis of the instrument. The needlecan be positioned so it needs much less area for maneuvering.

E) Multiple Ways to Hold and Operate the Instrument:

This design permits rotation of a curved surgical needle withoutrequiring a rotational motion of the wrist. Therefore, the instrumentcan be held in a position that may not allow wrist rotation and stillcarry out its function. In some situations the structures to be suturedlie very deep. Doing surgery on the vertebral column of very obesepatients is one such situation. For example, if the dura mater (amembrane that protects and envelops the spinal cord) is cut it needs tobe sutured. The dura mater lies within a deep constricted space. In avery obese patient the additional thickness of the adipose (fatty)tissue makes the dura lie even deeper from the surface. The surgeon mayhave to lean towards the patient and rotate the arm bearing the needledriver. This is necessary to get his forearm in a vertical position sohe can maneuver the instrument properly. The new needle driver designmay be operated while held like a t-shaped control lever. In thisposition the long axis of the instrument lies perpendicular to the palmof the hand. The surgeon does not need to position his forearmvertically in order to rotate the instrument. There is a powerfuladvantage when using this instrument that goes beyond any individualbenefit granted by its design features. The fact that suturing canbecome a more streamlined process permits a more continuous flow of theprocedure. The surgeon does not have to stop as often to think what heneeds to do next. He does not need to refocus on which segment of thetissue to grasp after looking away from the tissue to reposition aneedle. The end result is a procedure that is faster, moreenergy-efficient and safer for both the patient and the surgeon.

The invention is not limited to the precise configuration describedabove. While the invention has been described as having a preferreddesign, it is understood that many changes, modifications, variationsand other uses and applications of the subject invention will, however,become apparent to those skilled in the art without materially departingfrom the novel teachings and advantages of this invention afterconsidering this specification together with the accompanying drawings.Accordingly, all such changes, modifications, variations and other usesand applications which do not depart from the spirit and scope of theinvention are deemed to be covered by this invention as defined in thefollowing claims and their legal equivalents. In the claims,means-plus-function clauses, if any, are intended to cover thestructures described herein as performing the recited function and notonly structural equivalents but also equivalent structures.

All of the patents, patent applications, and publications recitedherein, and in the Declaration attached hereto, if any, are herebyincorporated by reference as if set forth in their entirety herein. All,or substantially all, the components disclosed in such patents may beused in the embodiments of the present invention, as well as equivalentsthereof. The details in the patents, patent applications, andpublications incorporated by reference herein may be considered to beincorporable at applicant's option, into the claims during prosecutionas further limitations in the claims to patentable distinguish anyamended claims from any applied prior art.

1. A non-handedness and ergonomic or any-handedness and ergonomic needledriver comprising at least one pull-locking mechanism as means to lockand unlock a suturing needle and a rotational element that rotates whilegrasping said suturing needle, wherein one complete motion in onedirection will begin with and the first locked position and continuewith the all possible locked positions during its process and end withthe unlocked position.
 2. A method of suturing tissues comprising: a)grasping a needle with a needle driver; b) driving said needle throughthe tissues being subjected to suture; c) substantially completing themovement of the needle through the tissues without releasing said needlefrom the tissue; d) grasping the needle at the apposite side and; e)repeat steps (a) to (d) until completion of the suturing process and;wherein the required needle driver is described in claim
 1. 3. Theprocess of claim 2, wherein the step (c) is achieved by turning the rodsof the needle diver.
 4. The process of claim 2, wherein the tissue beingsubjected to suture is selected from vascular, dura mater, musclefascia, tendinous and/or intestinal tissues.